Diabetes is a group of diseases marked by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. There are 23.6 million people in the United States, or 8% of the population, who have diabetes. The total prevalence of diabetes has increased 13.5% since the 2005-2007 time period. Diabetes can lead to serious complications and premature death, but there are well-known products available for people with diabetes to help control the disease and lower the risk of complications.
Treatment options for people with diabetes include specialized diets, oral medications and/or insulin therapy. The primary goal for diabetes treatment is to control the patient's blood glucose (sugar) level in order to increase the chances of a complication-free life. It is not always easy, however, to achieve good diabetes management, while balancing other life demands and circumstances.
Currently, there are two principal modes of daily insulin therapy. The first mode includes syringes and insulin pens that require a needle stick at each injection, typically three to four times per day, but are simple to use and relatively low in cost. Another widely adopted and effective method of treatment for managing diabetes is the use of a conventional insulin pump. Insulin pumps can help the user keep their blood glucose levels within target ranges based on their individual needs, by continuous infusion of insulin. By using an insulin pump, the user can match their insulin therapy to their lifestyle, rather than matching their lifestyle to how an insulin injection, for example, is working for them.
Conventional insulin pumps are capable of delivering rapid or short-acting insulin 24 hours a day through a catheter placed under the skin. Insulin doses are typically administered at a basal rate and in a bolus dose. Basal insulin is delivered continuously over 24 hours, and strives to keep one's blood glucose levels in a consistent range between meals and overnight. Some insulin pumps are capable of programming the basal rate of insulin to vary according to the different times of the day and night. Bolus doses are typically administered when the user takes a meal, and generally provide a single additional insulin injection to balance the carbohydrates consumed. Some conventional insulin pumps enable the user to program the volume of the bolus dose in accordance with the size or type of the meal consumed. Conventional insulin pumps also enable a user to take in a correctional or supplemental bolus of insulin to better control their blood glucose level to within their target range.
There are many advantages of conventional insulin pumps over other methods of diabetes treatment. Insulin pumps deliver insulin over time rather than in single injections and thus typically result in fewer large swings in one's blood glucose levels. Conventional insulin pumps reduce the number of needle sticks which the patient must endure, and make diabetes management easier and more effective for the user, thus considerably enhancing the quality of the user's life. Insulin pumps however can be cumbersome to use and are typically more expensive than other methods of treatment. From a lifestyle standpoint, the conventional pump, tubing, and injection set are inconvenient and bothersome for the user.
New advances in insulin therapy provide “wearable” drug infusion devices that are lower in cost and more convenient and comfortable to use than conventional insulin pumps. Some of these devices are intended to be partially or entirely disposable, and in theory provide many of the advantages of conventional insulin pumps without the initial high cost and inconvenience of conventional insulin pumps.
Wearable medical devices capable of performing similar functions as conventional insulin pumps are becoming increasingly more prevalent, but are still high in cost. Such medical devices are typically disposed of after a maximum of 3 days in operation. Driving factors for the duration of use for such medical devices include the viability of the injection site for a prolonged period and the limitations of the power supply in providing the necessary power over this period. Since common wearable medical devices are typically used for such short durations, it is necessary that the unit cost of each medical device be affordably low. In order to realize precise control over a user's insulin rate, typical wearable devices are required to communicate with a host device such as a Blood Glucose Monitor or a Personal Diabetes Monitor. Available wearable devices typically communicate with the host device using well-known wireless technology such as Bluetooth® or ZigBee®. Wireless communication technologies provide effective communication between the wearable device and a host device. However, the components necessary for realizing these technologies are relatively expensive, especially in an application using a disposable medical device. Not only do wireless communication technology components drive up the cost for providing the device, but they also consume sufficient power to shorten the life of the medical device, further driving up cost.
As indicated above, one major constraint of common wearable medical devices is the high cost of providing a reliable power supply for powering the necessary components to realize an effective and fully functional medical device. Further, there must be a balance in realizing a fully functional, affordable medical device and providing the medical device in a package that is convenient, comfortable and discreet for the user. Typical medical devices use a battery or battery array for providing power to the medical device. Such standard arrangements, however, unnecessarily drive up the cost of each medical device and can be bulky and relatively heavy. Further, the standard battery or battery array is usually disposed of at the same time as that of the used wearable medical device, thus contributing to unnecessary waste. Not until the cost of such medical devices is significantly reduced, will wearable medical devices be a viable option for many users.
Accordingly, there is a need in the art for providing more cost-effective wearable medical devices, so that many more diabetes patients can benefit from the advantages these devices provide.